33 Participants Needed

Elranatamab for Multiple Myeloma

AJ
KM
Overseen ByKrisma Montalvo
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests elranatamab, a new treatment for multiple myeloma, a type of blood cancer that has returned or hasn't responded to previous treatments. The goal is to evaluate elranatamab's effectiveness on its own for individuals who have tried 1 to 3 other treatment combinations. It suits those whose multiple myeloma has returned after treatment and who show measurable signs of the disease, such as specific protein levels in blood or urine tests. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that your last systemic treatment should be at least 2 weeks or 5 half-lives before starting the trial, and you can take a maximum of 160mg of dexamethasone during screening, but at least 7 days before starting therapy.

Is there any evidence suggesting that elranatamab is likely to be safe for humans?

Research has shown that elranatamab is generally well-tolerated by patients with relapsed or refractory multiple myeloma. Studies have found it to be effective and safe, with no new safety issues compared to other similar treatments. In one study, administering the treatment every two weeks reduced serious side effects from 58.6% to 46.6%, indicating its manageability. Another study confirmed that elranatamab was well-tolerated even in patients who had previous treatments targeting BCMA, a protein linked to multiple myeloma. Overall, the safety of elranatamab appears promising, with manageable side effects.12345

Why do researchers think this study treatment might be promising?

Elranatamab is unique because it targets multiple myeloma cells differently than traditional treatments like proteasome inhibitors, immunomodulatory drugs, or monoclonal antibodies. It is a bispecific antibody, meaning it can simultaneously bind to two different antigens: one on the cancer cell and another on immune cells, specifically T-cells. This dual binding action helps direct the body's immune system to attack and destroy the cancer cells more effectively. Researchers are excited about elranatamab because it offers a novel approach that could lead to more effective treatments with potentially fewer side effects, providing new hope for patients with multiple myeloma.

What evidence suggests that elranatamab might be an effective treatment for multiple myeloma?

Research has shown that elranatamab, the treatment under study in this trial, may effectively treat relapsed or refractory multiple myeloma, a type of blood cancer. One study reported that patients taking elranatamab had a median progression-free survival (PFS) of 17.2 months, meaning the disease did not worsen during and after treatment for this period. Another study found a median PFS of 27.3 months, suggesting the treatment might control the disease for over two years in some cases. Additionally, patients had a median overall survival (OS) of 24.6 months, which is the time from the start of treatment until death from any cause. These results suggest that elranatamab may significantly extend life and delay disease progression for patients with this challenging condition.46789

Who Is on the Research Team?

AJ

Ah-Reum Jeong

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed/refractory Multiple Myeloma who've had 1-3 prior treatments but haven't received BCMA-directed CAR T-cell therapy. They must have measurable levels of myeloma proteins in their blood or urine and be able to perform daily activities (ECOG status 0, 1, or 2).

Inclusion Criteria

Provision of signed and dated informed consent form
My side effects from previous treatments have mostly gone away.
Serum pregnancy test negative at screening for females of childbearing potential
See 9 more

Exclusion Criteria

I have no active infections or have controlled them for at least 14 days.
Pregnancy or lactation
Known or suspected hypersensitivity to the study intervention or any of its excipients
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab for relapsed/refractory multiple myeloma

1 year

Observation

Treatment-free observation period for patients with sustained MRD negative response for greater than 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Elranatamab
Trial Overview The study tests elranatamab's effectiveness on its own in patients whose Multiple Myeloma has returned after treatment or hasn't responded to previous therapies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ElranatamabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Published Research Related to This Trial

In the MagnetisMM-1 trial involving 88 patients with relapsed or refractory multiple myeloma, elranatamab demonstrated a significant overall response rate of 63.6%, with 38.2% of patients achieving a complete response or better, indicating its efficacy even in heavily pre-treated patients.
Elranatamab showed manageable safety with no dose-limiting toxicities during dose escalation, although some patients experienced cytopenias and cytokine release syndrome; the median progression-free survival was 11.8 months and overall survival was 21.2 months, suggesting promising durability of responses.
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial.Bahlis, NJ., Costello, CL., Raje, NS., et al.[2023]
Elranatamab, a bispecific antibody targeting BCMA and CD3, has shown promising results in treating relapsed refractory multiple myeloma, but its effectiveness in cases with central nervous system (CNS) involvement was previously unclear.
In a reported case, a 37-year-old male patient with CNS involvement of multiple myeloma was successfully treated with Elranatamab, suggesting potential for this therapy in challenging CNS-MM cases.
Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case.Mutlu, YG., Yıgıt Kaya, S., Maral, S., et al.[2023]
Elranatamab is a bispecific T cell engager that targets BCMA on multiple myeloma cells, effectively activating T cells to kill these cancer cells, and has received its first approval in the USA for treating adult patients with relapsed or refractory multiple myeloma after at least four prior therapies.
The approval was based on the drug's response rate and durability of response, with ongoing studies required to confirm its clinical benefits, indicating a promising new option for patients with difficult-to-treat multiple myeloma.
Elranatamab: First Approval.Dhillon, S.[2023]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40713551/
Comparison of outcomes with elranatamab and real world ...This study provides recent real world evidence of poor outcomes in TCE RRMM in the UK. PFS was longer among patients who received ...
Comparison of outcomes with elranatamab and real world ...Clinical outcomes in the ECA were poor (median PFS 3.71 months [95% confidence interval (CI) 2.73–4.73], median OS 11.00 months [8.02–18.10]).
A US subgroup analysis from MagnetisMM-3.Median (95% CI) PFS was 27.3 mo (4.3–NE). Median (95% CI) OS was NR (14.9–NE); the probability of survival at 30 mo (95% CI) was 55.8% (40.1- ...
Elranatamab in relapsed or refractory multiple myelomaPrimary and secondary efficacy endpoints. After a median follow-up of 14.7 months (range: 0.2–25.1 months), the primary endpoint was met with ...
ELREXFIO™ Shows Median Overall Survival of More Than ...Patients in MagnetisMM-3 demonstrated a median overall survival (OS) of 24.6 months, with median progression-free survival (PFS) of 17.2 months.
Safety and efficacy of elranatamab in patients with relapsed ...Elranatamab elicits deep and rapid heme responses in patients with relapsed AL amyloidosis, including minimal residual disease negativity.
Long‐term survival and safety of elranatamab in patients with ...Long‐term survival and safety of elranatamab in patients with relapsed or refractory multiple myeloma: Update from the MagnetisMM‐3 study
Efficacy and safety of elranatamab in patients with relapsed ...In pts with RRMM and prior exposure to BCMA-directed therapies, elranatamab was efficacious and well tolerated; no new safety signals were observed vs the BCMA ...
MagnetisMM-6 Data Suggest Safety, Manageability of ...Results from part 1 dose level G of the MagnetisMM-6 trial found elranatamab, daratumumab, and lenalidomide to be safe and manageable in NDMM.
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